ClinicalTrials.gg
CompletedNCT06898125Updated Aug 26, 2025

Evaluation of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy Results in Patients With Lipedema

An interventional study of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in Lipedema and Pain, sponsored by Giresun University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Giresun University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2023, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Lipedema with a site in Turkey — 18 open to participants now, 19 under way, none of them phase 3. Lipedema · Turkey.

Enrollment
9th of 14
33 · median 37
Started
2023
with 3 others
No phase
14 of 41
9 open now
Registered
13th of 41
by date

Among the 41 studies in Lipedema with a site in Turkey, this one is the 9th largest by enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2023, is one of 14 with no phase, and was the 13th registered.

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 33 is close to the median of 35 across 42 interventional studies indexed under Lipedema.

Browse Lipedema studies →

Open to participants now

18 of the 41 studies in Lipedema with a site in Turkey are open now, in 1 country. Each count lists the studies.

All 18 open studies →

Where they have run

Who these studies take

Of the 19 Lipedema studies recruiting now, 3 (16%) set no upper age limit and 16 (84%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Lipedema with a site in Turkey, or all of them as a file.
02

Study summary

The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.

Read the detailed description

The collected content will be transferred over SPSS 21.0. The normality distribution of the data will be evaluated with the Shapiro-Wilk Test. Data will be displayed as mean±standard deviation, median (1st quartile-3 quartile), or number(percent). In comparisons between the two consuming variables before and after exercise, if the values fit the normal distribution, the "paires sample t test" is used, if not, the Wilcoxon test is used. In the comparison of 3 groups, one-way ANOVA will be applied if it is normally distributed, and if it does not fit the normal distribution, the Kruskal Wallis test will be applied. Post-hoc analysis was planned for the printer, which was determined to determine the method statistically. To compare categorical protections is to use the Chi-square test. P \< 0.05 will be considered future.

03

Conditions studied

  • Lipedema
  • Pain

Browse trials for

Keywords

  • lipedema
  • complex decongestive therapy
  • extracorporeal shockwave therapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female
  • 18 years or older
  • Being diagnosed with lipedema according to Wold criteria
  • Having type 1, 2 and 3 lipedema
  • Having stage 1, 2 and 3 lipedema

Exclusion criteria

Exclusion Criteria:

  • Known rheumatic, endocrinological, neuromuscular, dermatological disease, kidney failure, liver failure and
  • Having undergone surgery for lipedema
  • Having poor circulation, open wound or infection in the lower extremities
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Complex Decongestive Therapy

    In this group, Complex Decongestive Therapy treatment will be applied to both lower extremities for two weeks, three sessions per week.

    Other: Complex Decongestive Therapy

  • Experimental
    Extracorporeal Shockwave Therapy

    This group will receive therapy for two weeks, three sessions per week, with the Modus ESWT® Radial Shockwave Therapy ( İnceler Medikal, Turkey ) brand ESWT device (35mm radial wavy head); 3000 impulse 15 Hz will be applied to both lower extremities with an average energy level of 3.5.

    Other: Extracorporeal Shockwave Therapy

  • Experimental
    Extracorporeal Shockwave Therapy and Complex Decongestive Therapy

    In this group, first Extracorporeal Shockwave Therapy and then Complex Decongestive Therapy treatment will be applied in the same session for two weeks, three sessions a week.

    Other: Extracorporeal Shockwave Therapy · Other: Complex Decongestive Therapy

Interventions

  • OtherExtracorporeal Shockwave Therapy

    Shock wave therapy is a new modality for the improvement of cellulite and lipedema; it is an easy, noninvasive, local therapy, without side effects, with short periods of application. Its original idea was the stimulation of lipid mobilization and improved lipolysis in areas with edema.

  • OtherComplex Decongestive Therapy

    Complex decongestive therapy (CDT) is one of the most important treatment modalities of choice for patients with this clinical condition. CDT has two phases: treatment and maintenance. The first stage consists of skin care, manual lymph drainage, kinesiotherapy and bandaging of the limb. Drainage can facilitate the return of lymphatic flow by stimulating the cisterna chyli. Next, kinesiotherapy is applied, which aims to activate the lymph. Finally, the limb is moistened and then a compressive bandage is applied aimed at creating a pressure gradient towards the areas where lymph absorption is greater. The second phase continues skin care, physical exercises and external compression applications using bandages with varying degrees of elasticity.

06

What researchers measure

Primary outcomes

  1. Dual-energy X-ray absorptiometry (DXA)

    DXA measurements were made with the patient in the supine position, with a radiation dose of 5.08 μSv, voltage 83.00 Kv, and current 0.2 mA from the head-to-heel distance by Osteosys Primus brand DXA device (Primus, X-ray densitometer, Osteosys Co. Ltd., Guro-gu, Seoul, Korea) will be made. With this measurement, the radiation dose received by the patient is very low and is below the daily natural radiation dose (7 μSv). With the obtained values, leg FM/total FM, android/gynoid fat ratios and fat mass (FM, fat mass) will be calculated using Osteosys Primus version 1.2.0 software. As a result of DXA measurements of the patients, Body Composition, Fat Mass, leg FM/total FM, Android/Gynoid FM values will be compared.

    Time frame: measurements will be taken before treatment and at the 2nd week after treatment.

  2. Volume measurement

    For volume measurements in the lower extremities of the patients, circumference measurements will be taken from the ankle to the thigh at 4 cm intervals; then these values will be calculated automatically with the Pythagorean theorem in the Excel program.

    Time frame: measurements will be taken before treatment and at the 2nd week after treatment.

Secondary outcomes

  1. Quality of life - Nottingham Health Profile (NHP):

    Nottingham Health Profile (NHP) is a general quality of life questionnaire that evaluates patients' perceptions of health problems and the effects of these problems on patients' activities of daily living. Pain, emotional reactions, sleep, social isolation, physical abilities and energy level subscales are evaluated. For each subscale, 0 points corresponds to the best health profile and 100 points corresponds to the worst health profile. The total NHP score is obtained by summing the subscale scores.

    Time frame: measurements will be taken before treatment and at the 2nd week after treatment.

  2. Algometric measurements

    The pain threshold of the patients will be measured from the right and left extremities with a Wagner brand manual algometer. Before the evaluation is made, the patients will be informed about how the measurement will be made, and they will be asked to give information as soon as the feeling of pressure returns to the feeling of pain. For the measurement, the compression applied by keeping the probe of the algometer device perpendicular to the measuring surface will be gradually increased at the rate of approximately 0.5kg/cm²/s. The compression applied at the point where the patients feel pain will be terminated. The measurement will be made twice in the same area and 4 minutes will be waited before the second measurement is taken. The average of the two measurements will be recorded as the pressure pain threshold.

    Time frame: measurements will be taken before treatment and at the 2nd week after treatment.

  3. Visual Analogue Scale (VAS)

    Pain intensity was measured with the Visual Analog Scale (0-10 mm; 0 means no pain, 10 means severe pain), which has a high reliability and validity in measuring musculoskeletal pain.

    Time frame: measurements will be taken before treatment and at the 2nd week after treatment.

07

Study locations

1 site
  • Giresun University Training and Research Hospital
    Giresun, Turkey (Türkiye)
08

References and documents

Publications

  • Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12. PubMed 33001552 ↗
  • Fife CE, Maus EA, Carter MJ. Lipedema: a frequently misdiagnosed and misunderstood fatty deposition syndrome. Adv Skin Wound Care. 2010 Feb;23(2):81-92; quiz 93-4. doi: 10.1097/01.ASW.0000363503.92360.91. PubMed 20087075 ↗
  • Siems W, Grune T, Voss P, Brenke R. Anti-fibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors. 2005;24(1-4):275-82. doi: 10.1002/biof.5520240132. PubMed 16403988 ↗
  • Brandao ML, Soares HPDS, Andrade MDA, Faria ALSC, Pires RS. Efficacy of complex decongestive therapy for lymphedema of the lower limbs: a systematic review. J Vasc Bras. 2020 May 29;19:e20190074. doi: 10.1590/1677-5449.190074. PubMed 34178058 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Apr 2025, 19 months.

Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 19 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2025
First posted
Mar 27, 2025
StartActual
Sep 1, 2023
Primary completionActual
Apr 30, 2025
CompletionActual
Jun 1, 2025
Last update
Aug 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06898125
Lead sponsor
Giresun University
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Sep 1, 2023
Primary completion
Apr 30, 2025
Completion
Jun 1, 2025
Last update
Aug 26, 2025

Study contacts

Mihrinur Dilvin TÜRKÖZ
study director · Giresun University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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